Occlusive device for medical or surgical use

ABSTRACT

An occlusive device includes a hollow cylindrical element which can be twisted axially in order to create a constricted region. The device also includes a body which can be deformed by transverse compression and which is applied against the inner wall of the aforementioned cylindrical element, the body having a through hole along the axis of the cylindrical element.

The present invention relates to an occlusive device for medical orsurgical use, and to a vascular occlusion device and a valve forsurgical or medical instruments.

The invention will find applications, in particular, in the manufactureand use of occlusive prostheses for all types of vessels in humans oranimals, prostheses that may also include transparietal and endovasculardevices.

The invention also relates to the field of surgical or medicalinstruments and in particular introducer type instruments that may beused during endovascular surgery, including percutaneous and/ortransparietal operations, which require the presence of obturationelements able to ensure that the introducer is sealed.

The quality of the occlusion is a constant problem according to thecurrent state of the art, both in the field of vascular prostheses andfor the creation of valves.

Document WO-A-0219926 relates to a vascular occlusion device comprisedof two expanding elements for attachment by support against two portionsof the vessel's wall, along with an intermediate section that can betwisted to an adjustable degree according to the relative position ofthe two expanding elements. A maximum striction area is thus created,defining the degree of occlusion.

According to this document, total or partial obturation is achieved bymeans of the twisting deformation of an element.

This technique provides a great ease of intervention and the ability tofine tine the degree of obturation.

There is, however, a need to further improve the sealing provided bythis type of device.

The present invention provides a solution to this by appended a secondocclusion element that acts in collaboration with the twist deformableelement.

In a preferred embodiment, the invention also possesses the advantage ofoffering additional tightness means in the form of seals that can beapplied to the wall of a vessel.

Still advantageously, for the creation of a vascular occlusion device,the invention allows both the constitution of an element able to provideobturation and guiding through cooperation with a removable guidepresent in the device during the procedure.

Other purposes and advantages shall appear during the followingdescription of a preferred embodiment of the invention, which isnevertheless not limiting.

The present invention relates to an occlusive device for medical orsurgical use comprising a hollow cylindrical element that can be twistedalong its axis to create a striction zone. It comprises a transversecompression deformable body, applied to the inner wall of thecylindrical element and possessing a opening oriented according to theaxis of the cylindrical element.

According to preferred variants, this device is such that:

-   -   The deformable body is attached to the inner wall of the        cylindrical element,    -   The deformable body is made from a polymer material,    -   there are two end parts, surrounding the cylindrical element and        whose angular position determines the torsion of said        cylindrical element.    -   The cylindrical element and the deformable body both have        circular cross sections.

The invention also relates to a vascular occlusion device comprising anocclusive device according to the invention.

This vascular occlusion device is advantageously embodied with thefollowing additional properties:

-   -   Two end parts, surrounding the cylindrical element and whose        relative angular position determines the torsion of said        cylindrical element, said end parts possessing means of        attachment to the wall of a vessel,    -   The attachment means are expanding elements,    -   It possesses a seal on the outer surface of at least one of the        expanding elements, said seal being appropriate for application        to the wall of a vessel,    -   It presents a peripheral obturation web extending from one end        of the deformable body to the edge of the corresponding        expanding element,    -   It possesses a removable guide oriented according to the axis of        the cylindrical element and crossing the opening of the        deformable body.    -   It possesses a removable sheath inserted between the wall of the        opening in the deformable body and the outer wall of the guide,    -   It comprises a removable sleeve surrounding the occlusive        device,

The invention also relates to a valve for surgical or medicalinstruments comprising a closeable passage and characterised by the factthat it comprises an occlusive device according to the invention.

In a preferred embodiment, this valve is such that the cylindricalelement can be twisted by means of two rings, each integral to one endof the cylindrical element.

The appended drawings are given as an example and do not limit theinvention. They represent only one embodiment of the invention and allowit to be easily understood.

FIG. 1 is a general view of the device concerned by the invention for avascular occlusion application.

FIG. 2 illustrates a step in the transparietal implementation of avascular occlusion device.

FIG. 3 shows an example of the end result of transparietal occlusion.

FIG. 4 is an exploded view of the different elements making up theocclusive device according to the invention in a preferred embodiment.

FIG. 5 is a side view of the deformable body and FIG. 6 is a section.

FIG. 7 is a side view of the deformable body as it is being deformed and

FIG. 8 is a section of this same situation.

FIG. 9 is a side view of the deformable body at the end of deformationand

FIG. 10 is a section of this same situation.

FIG. 11 illustrates a section of a sheath used for a vascular occlusiondevice.

FIG. 12 presents a longitudinal section of a vascular occlusion device.

FIG. 13 shows an example of insertion of an occlusive device accordingto the invention in an introducer valve.

The occlusive device according to the invention can be used in variousmedical or surgical fields. The remainder of the description shalloutline more specifically an embodiment applying the occlusive device tothe creation of a vascular occlusion device, along with an embodiment ofthe invention applying the occlusive device to valves for surgical ormedical instruments.

In general terms, the occlusive device comprises a hollow cylindricalelement that can be twisted according to its axis, this deformationcreating a striction zone advantageously widest towards the middle ofthe length of the hollow cylindrical element 1, although this is notlimiting.

The cylindrical element can be twisted by modifying the relative angularpositions of its ends.

Furthermore, the occlusive device comprises a transverse compressiondeformable body 2, show more precisely in FIGS. 4 to 10. This body 2possesses a shape and dimensions adapted to its application to the innerwall of the cylindrical element 1.

In a preferred embodiment, the deformable body 2 is furthermore attachedto said inner wall of the cylindrical element 1 in such a manner as tofollow this latter's deformation.

The body 2 further comprises a through hole 3 along the axis 4 of thecylindrical element 1.

The hole 3 offers a residual passage that can be closed to achieveobturation. In open position, the hole 3 allows the passage of fluid orsolid elements such as long objects in the case of an application tovalves for introducer type surgical instruments. Concerning applicationto the vascular occlusion device, the hole 3 is used to receive a guide7 that can be used when manipulating the occlusion device during thesurgical procedure.

Different materials can be used for constructing the body 2, and inparticular a polymer material, presenting, or not, shape memoryproperties. Other materials that can undergo transverse compressiondeformation during torsion of the hollow cylindrical element 1 may beused.

Still in a preferable manner and in reference to the drawings, theinvention's occlusive device possesses a hollow circular cross section,in particular concerning the cylindrical element 1 and the deformablebody 2.

The following describes in a more precise manner an embodiment of theocclusive device for a vascular occlusion device application.

In this context, reference is made to FIGS. 1 to 12, presenting aspecific embodiment of this application.

FIG. 1 shows in detail an example of structure that the cylindricalelement 1 can present. In particular, element 1 may be in the form of ametallic frame, Nitinol® based for example and presenting three distinctzones. The first zone, central, constitutes the cylindrical element 1itself and can be twisted as shown in FIGS. 2 and 3. Around thecylindrical element 1, two expanding elements 5 in the form ofself-expanding frames, are represented and may be in a configuration asshown in the field of endovascular prostheses. Expanding elements 5 and6 possess shape memory properties allowing them to undergo deploymentdeformation when released.

This release occurs through a sleeve 9 that surrounds the whole deviceprior to implementation by the practitioner. The cylindrical element 1and expanding elements 5 and 6 are held within the sleeve 9 in restingposition.

During implantation, the practitioner progressively removes the sleeve 9in such a manner as to release an initial expanding element to apply itagainst the wall of a vessel 10.

This removal can be achieved using a push element in the form of a long,hollow cylindrical element appropriate, by virtue of its width, to beapplied to the edge of the occlusive device to exercise a force contraryto removal of the sleeve 9, thus immobilising the occlusive deviceduring removal.

At this time, the vascular occlusion device is partially positioned, butexpanding element 5 is still in the sleeve 9. Rotation of the sleeve 9by the practitioner twists cylindrical element 1, thus creating astriction zone, as represented in FIG. 2.

When the desired degree of striction is achieved (this can be easilyadjusted by means of the amplitude of rotation implemented by thepractitioner), the other expanding element 5 is released from the sleeve9 by sliding it out (again using a push device if necessary). Thisrelease deploys the expanding element and applies it to the vessel wall10.

FIGS. 2 and 3 more specifically show a transparietal application of thepresent vascular occlusion device. In this context, it is expandingelement 6 that is applied to the internal wall and expanding element 5to the outer wall.

FIG. 4 provides a more detailed view of cooperation between the variousconstitutive elements of the vascular occlusion device.

In this context, the sheath 9 receives, in its inner volume, theassembly comprised of the cylindrical element 1 and the expandingelements 5 and 6. The cylindrical element 1 further receives, in itsinner volume, for application onto its inner wall, a deformable body 2with a through hole 3 along the device's axis.

The through hole 3 is itself able to receive a guide 7 duringmanipulations. In a preferred embodiment, a sheath 8 is inserted betweenthe inner wall of the through hole 3 and the outer surface of the guide7. The sheath 8, made for example from a metallic material, prevents anydeterioration of the body 2 during guide 7 movements and confersrigidity on the assembly. The guide 7 and the sheath 8 are designed tobe removable in such a manner as to be removed by the practitionerduring the operation, prior to twisting.

The combination of these constituents is more specifically representedin FIG. 12 according to a preferred embodiment.

FIGS. 5 to 10 display various states of mechanical stress of thedeformable body 2. In this context, FIGS. 5 and 6 respectivelyillustrate side and cross section views of the resting body 2. Thethrough hole 3 is perfectly free.

During twisting of the cylindrical element 1, the body 2 is compressedaccording to the direction of the arrows shown in FIG. 7. The throughhole 3 is then deformed, thus reducing its diameter as displayed in FIG.8. This leads to obturation, which may be total or partial.

By further emphasizing the torsion stress applied to the cylindricalelement 1, the transverse compression of the body 2 is increased untilcomplete obturation of the holes 2 is achieved. This situation isrepresented in FIGS. 9 and 10.

Preferably, the seal achieved by means of the occlusive deviceintegrated into the vascular occlusion device should be supported byadditional means.

More specifically, a seal 11, applied to the external periphery of oneof the expanding elements 6 may be used. An O ring seal, for example,may be used, made from a sufficiently deformable material to follow thedeformation of element 6 during its deployment.

The seal 11 is applied, through this deployment, to the wall of thevessel 10.

Still in a complementary manner to an occlusive device, the vascularocclusion device may include a web 12, as shown in FIG. 12. In itsresting position, the web 12 possesses a roughly tapered circular shape,possibly slightly bent, extending from one end 14 of the obturationelement and the edge 13 of the expanding element 6 located on the sameside. By establishing such a continuous web 12, a “funnel” effect isgenerated, thus avoiding any blood leakages out of the zone delimited bythe through hole 3.

When deploying the expanding element 6, the web 12 follows the corolladeformation.

Below we describe more specifically a second embodiment of the occlusivedevice of the invention for an application to valves for surgical andmedical instruments.

In particular, FIG. 13 illustrates the formation of such a valve 15 thatcan be integrated into or added to a body introduction instrument.

For this purpose, the valve 15 comprises a shell 18 able to receive, inits inner volume, an occlusive device comprising a cylindrical element1.

The valve 15 furthermore comprises a proximal end with an opening 19 forpassing elements during introduction, along with an additional opening21.

The distal end 20 of the valve 15 is able to receive an additional valveelement or a simple angular control element.

According to this application, the cylindrical element 1 is surroundedby rings 16 and 17, whose relative angular position can be adjusted insuch a manner as to ensure the twisting of element 1.

Though not represented, element 1 receives, in its inner volume, adeformable body 2.

According to the example, rotation of ring 17, caused by manipulatingthe distal end 20 of valve 15, alters the relative angular position ofrings 16 and 17 and causes twisting of element 1. This twistingdeformation causes a transverse compression of the body 2 due to theresulting striction.

It is thus possible to totally or partially open or close through hole 3by altering the position of ring 17, and this while ring 16 is fixed.

Of course, this embodiment is only an example and other variants may beconsidered.

In particular, ring 16 may be free to rotate, while ring 17 could befixed. Furthermore, the rings 16 and 17 may additionally be movedtogether or apart, for example by means of a helicoidal runner type linkbetween the housing 18 of the valve 15 and the ring 17.

In the context of this application, the cylindrical element 1 comprisesa sealed wall and may be made, in particular, from a woven (or not)textile material, or from a polymeric material such as P.T.F.E. (PolyTetra Fluoro Ethylene).

REFERENCES

-   1. Cylindrical element-   2. Deformable body-   3. Hole-   4. Axis-   5. Expanding element-   6. Expanding element-   7. Guide-   8. Sheath-   9. Sleeve-   10. Vessel wall-   11. Seal-   12. Web-   13. Edge-   14. End of body-   15. Valve-   16. Ring-   17. Ring-   18. Housing-   19. Opening-   20. Distal end-   21. Opening

1. Occlusive device for medical or surgical use, comprising a hollowcylindrical element (1) that can be twisted according to its axis tocreate a striction zone, comprising a transverse compression deformablebody (2) applied to the inner wall of the cylindrical element (1), andcomprising a through hole (3) according to axis (4) of the cylindricalelement (1).
 2. Device according to claim 1, wherein the deformable body(2) is attached to the inner wall of the cylindrical element (1), 3.Device according to claim 1, wherein the deformable body (2) is madefrom a polymer material,
 4. Device according to claim 1, comprising twoend parts, surrounding the cylindrical element (1) and whose angularposition determines the torsion of said cylindrical element (1). 5.Device according to claim 1, wherein cylindrical element (1) and thedeformable body (2) both have circular cross sections.
 6. Vascularocclusion device, comprising the occlusive device according to claim 1.7. Device according to claim 6, comprising two end parts, surroundingthe cylindrical element (1) and whose relative angular positiondetermines the torsion of said cylindrical element (1), said end partspossessing means of attachment to the wall of a vessel.
 8. Deviceaccording to claim 7, wherein the attachment means are expandingelements (5 and 6).
 9. Device according to claim 8, comprising a seal(11) on the outer surface of at least one of the expanding elements (5and 6), said seal (11) being appropriate for application to the wall ofa vessel.
 10. Device according to claim 8, comprising a peripheralobturation web (12) extending from one end of the deformable (2) body(14) and the edge (13) of the expanding element (5, 6).
 11. Deviceaccording to claim 6, comprising a removable guide (7) positionedaccording to the axis (4) of the cylindrical element (1) and crossingthe hole (3) in the deformable body (2).
 12. Device according to claim11, comprising a removable sheath (8) inserted between the wall of thehole (3) in the deformable body (2) and the outer wall of the guide (7),13. Device according to claim 6, comprising a removable sleeve (9)surrounding the occlusive device.
 14. Valve (15) for surgical or medicalinstrument, comprising a closeable passage the valve comprising, anocclusive device according to claim
 1. 15. Valve (15) according to claim14, wherein cylindrical element (1) can be twisted by means of two rings(16 and 17), each of which is integral to one end of the cylindricalelement (1).